Guidance and regulation

What you need to do to supply authorised medicines from Great Britain to Northern Ireland.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 23 January 2023

Guidance on whether or not your product is a medical device.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 April 2024

Submission dates and how the submissions using the EC decision reliance procedure work.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 12 September 2023

How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 12 June 2023

How to change the ownership from one marketing authorisation (MA) holder to another.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 17 November 2023

There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 16 April 2024

This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 15 October 2021

How to apply for marketing authorisation via this new procedure.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 18 November 2022

Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 20 January 2022

The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 February 2021

Guidance on what approved bodies are, what they do and how you can become one.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 July 2023

Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 29 September 2023

An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Guidelines to help mitigate and manage medicine shortages.

• From: Department of Health and Social Care
• Updated: 4 September 2023

Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 23 February 2021

Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 2 October 2015

How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 30 December 2022